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FDA 510(k)

Regulora

K-Number: K211463 · 2021-11-24

ApplicantMetame Health, Inc.
Decision Date2021-11-24
Product CodeQMY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Regulora is the device name listed in this FDA 510(k) record. The listed applicant is Metame Health, Inc.. It received FDA 510(k) clearance on 2021-11-24 under 510(k) number K211463. The device is classified under product code QMY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Regulora?

Regulora is a medical device that received FDA 510(k) clearance on 2021-11-24. The listed applicant is Metame Health, Inc.. The 510(k) number is K211463.

When did Regulora receive FDA 510(k) clearance?

Regulora received FDA 510(k) clearance on 2021-11-24, under 510(k) number K211463.

Who is the listed applicant for Regulora?

The FDA 510(k) record lists Metame Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Regulora?

The FDA product code for Regulora is QMY.

Related Devices (Code: QMY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211372Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)Mahana Therapeutics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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